Team Member - BiopharmPK- IVIVC- PBPK

Provide advanced Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics Modeling (PBBM) support across the drug development lifecycle, contributing to biopharmaceutics risk assessment, formulation strategies, and regulatory submissions for global markets.

Develop and apply PBPK/PBBM models to support drug development.

- Build, verify, and utilize PBPK/PBBM models to assess biopharmaceutics risks, perform virtual bioequivalence (BE) studies, and guide formulation development Conduct sensitivity and uncertainty analyses, perform in vitro-in vivo correlation (IVIVC) and in vitro-in vivo relationship (IVIVR) studies, and generate submission-ready documents to streamline regulatory processes

Support regulatory strategies and global submissions

- Collaborate with cross-functional teams to apply PBPK/PBBM approaches in preparing robust regulatory submissions, aligned with global requirements such as USFDA and EMA guidelines Justify biowaivers effectively to minimize the need for costly BE studies, thereby optimizing timelines and resource utilization

Promote adoption of PBPK/PBBM approaches.

- Build awareness and drive implementation of PBPK/PBBM frameworks by partnering with internal stakeholders and collaborating with external technical consultants Provide solutions for project challenges and ensure seamless integration of these techniques into development workflows

Contribute to knowledge building and capability enhancement.

- Mentor team members on modeling and simulation techniques, continuously update technical knowledge through literature reviews, and contribute to scientific publications Engage in internal training programs to enhance the organizations modeling capabilities and readiness for future challenges

Ensure cross-functional collaboration for project success.

- Coordinate with internal teams such as Formulations RD, Clinical RD, Analytical/Formulations, and Regulatory Affairs to align strategies and resolve development challenges Liaise with external consultants to tackle technical complexities, ensuring project deliverables are achieved without compromise

- Driving alignment and decision-making in decentralized cross-functional teams
- Ensuring adherence to regulatory expectations for PBPK/PBBM submissions across diverse geographies
- Balancing innovation and cost optimization by minimizing reliance on BE studies through biowaiver filings

Internal

- Formulations RD team for project execution and updates
- , Clinical RD for aligning on clinical study design and status
- , Analytical/Formulations team for analytical data support and insights- , Regulatory department for submission preparation and query resolution

External

- Technical consultants for inputs, troubleshooting, and problem resolution
- , Global regulatory bodies during submission reviews and queries

- Headcount: 3000
- Team Size (Direct): 0
- Team Size (Indirect): 0
- Number of PBPK/PBBM Models Developed: 15 annually
- Regulatory Submissions Supported: 10 annually
- Adoption of PBPK/PBBM Approaches: 5 projects annually
- Biowaiver Filings Approved: 12 annually
- Cross-Functional Collaboration Metrics: 90% adherence

Decisions

- Finalize biorelevant in-vitro methods and formulation strategies
- Determine the technical readiness of documents related to dossier submissions
- Approve virtual BE simulation outputs and biowaiver justifications

Recommendations

- Propose budget-related approvals for software purchases and consultant hiring
- Recommend formulations for bioequivalence studies to HOD and cross-functional teams

Skills Knowledge: Masters degree in Pharmaceutical Sciences, Pharmacokinetics, or related fields (advanced degrees preferred). Relevant Experience: 5-8 years in PBPK/PBBM modeling, biopharmaceutics, pharmacokinetics, bioequivalence, formulation bridging, and regulatory submissions. Demonstrated expertise in biowaiver strategies and risk assessments.